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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K162186
Device Name BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
Applicant
BRIGHTWAY HOLDINGS SDN BHD
LOT 1559, JALAN ISTIMEWA, BATU BELAH
KLANG,  MY 42100
Applicant Contact G. BASKARAN
Correspondent
BRIGHTWAY HOLDINGS SDN BHD
LOT 1559, JALAN ISTIMEWA, BATU BELAH
KLANG,  MY 42100
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LZC  
Date Received08/04/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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